Global Pharmacovigilance (PV) Scientist, Manager- Oncology

Amgen seeks a Global Pharmacovigilance Manager to lead safety surveillance and signal management for oncology products across development and post-marketing phases. The role involves conducting safety analyses, preparing regulatory reports, supporting clinical development, and collaborating with cross-functional teams to ensure product safety and inform benefit-risk decisions.

Responsibilities

• Lead signal detection, validation, and management using multiple safety data sources and methodologies
• Conduct scientific evaluation of adverse events from clinical trials, post-marketing surveillance, and literature
• Author and review aggregate safety reports and regulatory submissions to support product lifecycle
• Provide strategic safety input to clinical protocols, study reports, and risk management plans
• Represent Global Patient Safety in governance committees and cross-functional decision-making bodies

Requirements

• Expertise in pharmacovigilance, signal detection, and safety evaluation methodologies
• Experience preparing aggregate safety reports (PBRERs, PSURs, DSURs, safety assessments)
• Knowledge of global regulatory requirements, GVP guidance, and ICH standards
• Strong scientific and medical evaluation skills for adverse events and safety data
• Experience collaborating with clinical development, regulatory affairs, and safety teams
• Demonstrated ability to communicate complex safety analyses to governance committees